Fecal Microbiota Transplants for Inflammatory Bowel Disease Treatment: Synthetic- and Engineered Communities-Based Microbiota Transplants Are the Future

Table 1

Completed clinical trials investigating FMT as a potential therapy for IBD.

Feature of study	Completed RCT trials				Completed SGA trials
	Moayyedi et al.	Rossen et al.	Paramsothy et al.	Costello et al.	NCT02108821	NCT03106844	NCT01560819	NCT02049502
Study design	Double-blind RCT	Double-blind RCT	RCT	RCT	Single group assignment	Single group assignment	Single group assignment	Single group assignment
Number of patients (placebo)	75 (37)	48 (25)	81 (40)	73 (35)	23 (NA)	50 (NA)	9 (NA)	8 (NA)
Treatment regimen	6 FMTs	2 FMTs	40 FMTs	3 FMTs	1 FMT	1 FMT	20 FMT	Single FMT
Comparator (placebo)	Water	Autologous FMT	Water	Autologous FMT	None	None	None	None
Route of administration	Lower GI, enema	Upper GI, duodenal tube	Lower GI, retention	Lower GI, retention	Upper GI, jejunal intubation	Lower GI, colonoscopy	Retention enema	Lower GI, sigmoidoscopy
Stool donor per suspension	Single donor	Single donor	Multiple donors	Multiple donors	NA	NA	Multiple donors	Single donor
Follow-up	6 weeks	12 weeks	8 weeks	8 weeks	26 weeks	8 weeks	4 weeks	13 weeks
Primary endpoint	Endoscopic remission	Endoscopic remission	Endoscopic response	Endoscopic remission	Occurrences of adverse events	Recurrence of CDI in IBD patients	Improvement in PUCAI score	Improvement of pouchitis symptoms based on mPDAI
Primary outcome FMT versus comparator	24% (9/38) versus 5% (2/37)	30% (7/23) versus 20% (5/25)	27% (11/41) versus 8% (3/40)	32% (12/38) versus 9% (3/35)	52.17% (12/23)	8.2% (4/49)	Improvement in PUCAI score in all patients; 100% (9/9)	Improvement in mPDAI score in all patients; 100% (9/9)

Abbreviations: FMT: fecal microbiota transplant; GI: gastrointestinal; RCT: randomized controlled trial; UC: ulcerative colitis; mPDAI: modified pouchitis disease activity index; PUCAI: Pediatric Ulcerative Colitis Activity Index; SGA: single group assignment.